FDA 510(k), K112422, CRAG LATERAL FLOW ASSAY (LFA)
FDA 510(k), K112422, CRAG LATERAL FLOW ASSAY (LFA)
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510(K) Number: K112422
Device Name: CRAG LATERAL FLOW ASSAY (LFA)
Manufacturer:
Device Classification Name: Antisera, Latex Agglutination, Cryptococcus Neoformans
Regulation Number: 866.3165
Classification Product Code: GMD
Date Received: 08/23/2011
Decision Date: 03/28/2012
Regulation Medical Specialty: Microbiology
Device Name: CRAG LATERAL FLOW ASSAY (LFA)
Manufacturer:
Device Classification Name: Antisera, Latex Agglutination, Cryptococcus Neoformans
Regulation Number: 866.3165
Classification Product Code: GMD
Date Received: 08/23/2011
Decision Date: 03/28/2012
Regulation Medical Specialty: Microbiology